Are you detail-oriented and passionate about clinical trial documentation and regulatory compliance? eClinical Solutions is hiring for the position of QC Specialist (eTMF) at its Bangalore office. This full-time opportunity is ideal for professionals with experience in clinical trial documentation, quality control, and electronic Trial Master File (eTMF) systems.
🌐 About eClinical Solutions
eClinical Solutions empowers life sciences organisations to accelerate clinical development through its Illuminate Clinical Data Cloud and expert data services. The company provides centralised access to clinical data and advanced analytics, enabling smarter and faster decision-making. With a focus on digital trials, eClinical Solutions is transforming how clinical research is conducted globally.
📍 Job Overview
Job Title: QC Specialist (eTMF)
Location: Bangalore, Karnataka, India
Department: Clinical Documentation & Quality
Employment Type: Full-Time
🎯 Role Summary
The Trial Master File (TMF) Quality Control Specialist plays a vital role in ensuring the accuracy, completeness, and compliance of essential clinical trial documents. This position requires a strong understanding of regulatory guidelines and the ability to work collaboratively with cross-functional teams to maintain high-quality documentation standards.
🔍 Key Responsibilities
Conduct thorough quality control reviews of TMF documents to ensure completeness, accuracy, and alignment with regulatory standards (ICH-GCP, FDA, EMA).
Verify that all required documents are present and properly indexed within the eTMF system.
Identify and resolve discrepancies, missing documentation, and deviations from SOPs.
Collaborate with study teams, clinical operations, data management, and regulatory affairs to address findings.
Maintain detailed records of QC findings and monitor corrective actions.
Support audit and inspection readiness by preparing the TMF for internal and external reviews.
Contribute to TMF health reports and performance metrics.
Assist in developing and updating study-specific TMF Plans and Indexes.
Provide feedback for continuous improvement of TMF processes and systems.
Train and mentor junior QC specialists to ensure consistent quality delivery.
Ensure compliance with internal SOPs and industry regulations.
🧠 Candidate Profile
Education & Language:
Bachelor’s degree or higher in a relevant field (e.g., Computer Science, Life Sciences, Health Sciences).
Excellent command of English (written and spoken).
Professional Experience:
2–3 years of experience in the pharmaceutical or biotechnology industry, preferably in clinical documentation or quality control.
Strong knowledge of ICH-GCP, DIA TMF Reference Model, and regulatory requirements (FDA, EMA).
Experience with eTMF systems such as Veeva or Trial Interactive.
Familiarity with 21 CFR Part 11, clinical trial methodology, and software development lifecycle is a plus.
### Skills:
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Excellent attention to detail and organisational skills.
Strong communication and teamwork abilities.
Ability to manage multiple priorities and work independently.
Application Link: https://job-boards.greenhouse.io/eclinicalsolutions/jobs/4745630007?gh_src=44f4ebe87us
📢 Final Thoughts
This is a fantastic opportunity for professionals looking to grow in the field of clinical documentation and quality assurance. If you have a keen eye for detail and a passion for maintaining regulatory compliance in clinical trials, the QC Specialist (eTMF) role at eClinical Solutions could be your next career milestone.